Vanatol

Product NDC

58809-359

11-digit product format

588090359

Labeler code

58809

Product ID

58809-359_96862d24-092e-4144-e053-2995a90a7147

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

butalbital, acetaminophen and caffeine

Dosage form

SYRUP

Route

ORAL

Labeler

GM Pharmaceuticals

Application

ANDA040387

Marketing category

ANDA

Marketing start

2017-07-01

Marketing end

0000-00-00

Substance

BUTALBITAL; ACETAMINOPHEN; CAFFEINE

Active strength

50 mg/15mL; mg/15mL; mg/15mL

Pharmacologic classes

Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]

DEA schedule

CIII

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record